Key Responsibilities

• Identifies and resolves complex exceptions to work assignments.
• Summarizes, analyses, draws conclusions and makes appropriate decisions from test results or other process related findings.
• Read and interpret technical drawings, procedures, and protocols.
• Identify Manufacturing process defects (scrap, nonconforming material, customer complaints) by dispositioning non-conforming material, assisting in identification of primary root causes and understanding corrective and preventative actions. May be responsible for working with process owner to bound product stops and document release criteria.
• Has the responsibility and independent authority to make decisions related to product quality, including the disposition of non-conforming product.
• Participates in Customer Complaints investigation for areas under their control.
• Document investigation findings in analysis report on GCS2.
• Become a trainer for the Software related with complaints handling process (GCS2), as required.
• Continually seeks to drive improvements in product and process quality.
• Checks and provides support in the execution and investigation of CAPAs, NCEP, Failure Mode Investigations, etc.
• Evaluates new equipment and processes and participates in the transfer of new products.
• Knowledgeable on QSR and ISO/MDD standards, constantly promoting awareness of best industry practices, making appropriate decision on a daily basis utilizing the quality engineering manager/site QA Director as the final arbitrator on critical quality decision.
• Fully conversant with validation techniques and associated regulatory requirements including analysis of customer feedback and complaints.
• Responsible for reviewing and developing process validation protocols and reports. Support other functional areas during the validation activities.
• Evaluates in conjunction with EHS new equipment/processes/chemicals for environmental impact/effect to eliminate or lessen such impacts/effects.
• Knowledgeable on Risk Management, BSEN 14971 requirements.
• Compiles and analyses operational, test and validation data to establish technical specifications and performance standards for newly designed or modified products and processes.
• May participate directly in a new product/technology transfer to ensure compliance to all internal and regulatory requirements.
• Uses knowledge of Six Sigma, Statistical Analysis and Lean principles to investigate and solve problems and improve quality.
• Assure that all laboratory equipment is in compliance to perform the analysis activities (calibration, safety, cleanliness).
• Gives technical guidance to Associate Quality Engineer, Technician and Inspection staff.
• Is a good team member, fully motivated to achieve and demonstrate best practices in line with the department and Site objectives.
• Deals with suppliers, other engineering disciplines within and outside of the Site and customers should the need arise.
• Is familiar with the internal auditing process.

Requirements

• Bachelor’s Degree in Engineering, Technology, or a related Science discipline.
• Minimum 5 years of relevant experience in a regulated industry, preferably within the medical device industry.
• Experience in running and reviewing nonconforming event risk assessments and investigations.
• Experience working in quality engineering, process validation, and quality system compliance.
• Strong analytical and problem-solving skills with the ability to support quality and operational excellence initiatives.

Required Skills

• Good understanding of ISO 13485 requirements and QMSR or equivalent quality system regulations.
• Experience running/owning nonconforming event risk assessments and investigations.
• Ability to interpret, execute, and support the full validation lifecycle from planning to reporting.
• Strong analytical skills, including Root Cause Analysis (RCA).
• Statistical analysis skills using tools such as Excel and Minitab.
• CAPA, NCEP, and Failure Mode Investigation experience.
• Validation protocol and report development/review.
• Risk Management and BSEN 14971 knowledge.
• Six Sigma, Statistical Analysis, and Lean methodologies.
• Customer complaint investigation and complaint handling experience.
• Cross-functional collaboration and stakeholder management skills.
• Strong written and verbal communication skills.